510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K892521Substantially Equivalent

Cymed Microskin(r) Disposable Irrigation Sleeve

Cymed, Inc., Hayward CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K892521 is the FDA 510(k) clearance record for CYMED MICROSKIN(R) DISPOSABLE IRRIGATION SLEEVE, a class I device, cleared for Cymed, Inc. on under FDA product code FZS (Curette, Surgical, General Use). FDA records list one 510(k) clearance for Cymed, Inc. As of , FDA records show no recalls naming K892521.

Clearance record

Decision date
Received
(20 days to decision)
Product code
FZS Curette, Surgical, General Use
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Cymed, Inc. 3447 Investment Blvd., Hayward CA
Third party review
No

Clearances, product code FZS

Trailing 12 months

FDA records hold no clearances under product code FZS in the trailing twelve months.

FDA records show no clearances under product code FZS in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FZS, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260